A Study to Assess 18-Methoxycoronaridine (18-MC HCl) in Healthy Volunteers
A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Single/Multiple Day Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of 18- Methoxycoronaridine (18-MC HCl) Administered Orally to Normal Healthy Volunteers
1 other identifier
interventional
108
1 country
1
Brief Summary
The primary objective of this study is to assess the safety and tolerability of a single day dosing and a separate multiple day dosing of 18-MC HCl administered orally, each part of the study having a different set of healthy male and female volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2020
CompletedFirst Posted
Study publicly available on registry
March 3, 2020
CompletedStudy Start
First participant enrolled
April 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 13, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedJanuary 5, 2022
January 1, 2022
1.7 years
February 18, 2020
January 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the safety, using incidence and severity of adverse events, of a single and multiple-day dosing of 18-MC administered orally.
Safety and tolerability will be assessed by the incidence and severity of adverse events (AEs). An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.
Up to 28 days (SAD) and 42 days (MAD)
Secondary Outcomes (5)
Maximum Observed Plasma Concentration (Cmax)
48 post dose - Day 1 and Day 7
Time to Reach Maximum Observed Plasma Concentration (Tmax)
48 hours post dose - Day 1 and Day 7
Area Under the Curve from Time Zero to Last Quantifiable Concentration (AUClast)
AUC(t0-48hr) pg*hr/mL
Terminal Elimination Half-Life (t1/2)
48 hours post dose - Day 1 and Day 7
As an exploratory objective, the concentration of metabolites in plasma and urine may be determined
Up to 28 days (SAD) and 42 days (MAD)
Study Arms (2)
18-MC SAD Study
EXPERIMENTALIn Part 1, healthy participants will be randomized into cohorts to receive 18-MC HCl or placebo twice in 1 day.
18-MC MAD Study
EXPERIMENTALIn Part 2, healthy participants will be randomized into cohorts to receive 18-MC HCl or placebo twice a day for 7 consecutive days.
Interventions
Eligibility Criteria
You may qualify if:
- Written informed consent before any study-specific procedures.
- Healthy male and female volunteers aged 18 to 55 years (inclusive) with suitable veins for cannulation and repeated venipuncture.
- Female subjects of both childbearing and nonchildbearing potential will be considered, with certain conditions met
- Female subjects must agree not to breastfeed starting at screening and throughout the study period.
- Male participants must agree to practice abstinence; be surgically sterilized; or agree to use of a condom, plus effective contraception.
- Have not smoked or used any tobacco or nicotine-containing products in the 3 months before screening and agree not to smoke during the entire study.
You may not qualify if:
- History of any clinically important disease or disorder that, in the opinion of the investigator, would affect the ability of the participant to participate in the study
- History or presence of gastrointestinal, hepatic, cardiac, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of study drug.
- History of gastrointestinal ulcer disease, inflammatory bowel disease, or frequent indigestion symptoms
- Adequate organ function
- History of seizures or epilepsy.
- Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV).
- Any clinically significant cardiovascular abnormalities
- Known or suspected history of substance abuse disorder
- History of alcohol abuse or excessive intake of alcohol
- Positive screen for drugs of abuse, cotinine (nicotine) or alcohol
- Has received another new chemical entity (defined as a compound, which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within 30 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dr. Sam Salman
Perth, Australia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2020
First Posted
March 3, 2020
Study Start
April 14, 2020
Primary Completion
December 13, 2021
Study Completion
December 31, 2021
Last Updated
January 5, 2022
Record last verified: 2022-01